MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VIKING; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	87071
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.The returned device matches the upn number provided by the customer.The electrode 6 had shifted distally exposing approximately the bottom 1/4th of the silver epoxy/insulation ring indent.Tip motion was evaluated against the josephson curve template; the tip was curving in the expected direction however was misshaped.X-rays did not reveal any obvious anomalies.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
Event or Problem Description
Reportable based on analysis completed on 12 jul 2019.It was reported that a viking catheter had its curvature reversed.The procedure was completed via a alternate method with no patient complications.However, analysis of the returned device revealed exposed silver epoxy.

• Brand Name: VIKING
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 8875522
• Report Number: 2134265-2019-09487
• Device Sequence Number: 2624982
• Product Code: DRF
• UDI-Device Identifier: 08714729878162
• UDI-Public: 08714729878162
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K971265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/17/2020
• Device Model Number: 87071
• Device Catalogue Number: 87071
• Device Lot Number: 0022813072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2019
• Initial Report FDA Received Date: 08/08/2019
• Patient Sequence Number: 1